Regultory Affairs Associate

Kaztronix

Durham, NC

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JOB DETAILS

SKILLS

Administrative Certification, Adobe Acrobat, Billing, Biology, Biotech and Pharmaceutical, Chemistry, Clinical Laboratory, Communication Skills, Cross-Functional, Detail Oriented, Documentation, Documentation Format, Documentation Review, Establish Priorities, FDA (Food and Drug Administration), File Maintenance, Health Canada, Licensing, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft Word, Multitasking, Organizational Skills, Pharmacy, Plasma, Regulations, Regulatory Requirements, Reporting Dashboards, Surveillance, Time Management

LOCATION

Durham, NC

POSTED

22 days ago

Looking for someone detail-oriented, there are written instructions they will be expected to follow, as well as verbal instructions. This person needs to be able to work independently and prioritize their work. They will be routinely corresponding with Regulatory authorities, so communication skills will be important. A background in regulatory quality focus

This position is scheduled to be hybrid. M Tu W in office and Th Fr remote. However, this will depend on whether the candidates have remote work experience and have their home set up to perform the work.

Summary:
Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities associated with Source Plasma collection within the United States of America, Canada and Rest of World (ROW). This includes activities associated with US Food and Drug Administration (FDA) licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical Laboratory Improvement Amendments (CLIA) activities, Plasma Protein Therapeutics Association (PPTA) membership and certification, Client accreditation, state/province requirements and ROW licensing activities as applicable.

Primary responsibilities:
Accurately prepare regulatory applications required by federal and other regulatory authorities, as well as industry affiliates for review prior to application submission.
Research internal documents, complete applications, and forms; prepare cover letters and summaries; assemble and format applications in a manner to facilitate the review process.
Submit and monitor application submission for timely review and acceptance with the ability to respond to regulatory agency inquiries.
Provide updates to management on the status of applications
Escalate to management urgent and time-sensitive matters that impact regulatory compliance.
Maintain files contemporaneously for transparency and timelines.
Maintain applicable shared mailboxes, dashboards and accounts related to administrative licensing activities.
Archive and distribute applications electronically and in hardcopy.
Record the details of pertinent conversations and/or written interactions with a regulatory authority, when applicable.
Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.
Provide registration and licensing documentation to stakeholders in a timely manner.
Assist with evaluation of regulatory changes for impact to the business.
Process and track all invoices to ensure prompt payment associated with licensing activities.

Knowledge skills and abilities:
"" Ability to work with limited supervision and initiate contacts essential to submission preparation.
" Understanding of the regulatory requirements for licensing applications and reporting.
" Ability to follow standardized processes in a regulated environment.
" Ability to review documents in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.
" Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a deadline driven environment.
" Ability to effectively use Microsoft Office (particularly Word and Excel) and Adobe PDF to create, edit, and format documents.
" Ability to complete assigned tasks within the required timelines.
" Ability to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications.
" Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion.
" Works collaboratively as part of the regulatory team to meet group objectives.
" Models and demonstrates high standards of integrity, trust, openness, and respect for others.
" Take initiative; look for opportunities to act and contribute to the team's success.
" Ability to demonstrate openness to constructive feedback in order to improve on a continuous basis.
" Makes good use of unsupervised time.
" Ability to connect individual responsibilities with company mission and department goals to meet business objectives while being a good representative of the company."

Education:
" Bachelor's Degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology).

Experience:
"" Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry.
" Experience with Microsoft Office.
" Experience with Adobe PDF.
" Experience in plasma collection, pharmaceutical industry, or a regulated field."

About the Company

Kaztronix

Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.kaztronix.com/

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